Safety Associate

Safety Associate

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients faster, safer, better.

We dont make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency

The Safety Associate (SA) assists with successful planning, implementation, and execution of contracted safety management activities. Under the guidance of the Safety Manager, the SA is responsible for monitoring and processing Adverse Events, supporting CEC and DSMB management, assisting with applicable regulatory reporting, and serving as a resource on safety-related issues. Assures clear client and internal team communication, process documentation, and compliance with applicable US and international regulations, Good Clinical Practices and procedures set forth by RQM+ and its clients.

Responsibilities :

• Exhibit subject matter expertise in clinical trial conduct and safety with a focus on medical device studies, as well as combination products and software as medical device.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Gathers, reviews and interprets source documentation from clinical sites to formulate a cohesive narrative for safety events.
• To perform Pharmacovigilance per project requirement including but not limited to, collecting, and tracking incoming Adverse Events(AE) / endpoint information.
• Determine initial / update status of incoming events.
• Review and evaluate adverse events to determine if they meet regulatory reporting requirements.
• Database entry in commercial and validated safety database.
• Coding AEs in accordance with MedDRA and WHO Dictionary and writing case narratives, literature related activities as per internal / project timelines.
• Assist in development of project-specific safety management plan, safety committee charters, procedures, workflows, and templates.
• Safety Committee support and coordination; obtain electronic signatures, onboarding members, member management, manage and facilitate meetings, prepare materials, assist with documentation, document maintenance, and liaising with study personnel.
• Ensure to meet the expected productivity, quality standards and delivery standards per project requirements and department KPIs.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• Contribute to identification, development, and implementation of safety management initiatives and process improvements.
• Assist with risk assessment activities and implementation of effective control measures and corrective action solutions, as required.
• To mentor new team members, if assigned by the Sr. Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges / issues or successes.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements related to device safety and pharmacovigilance.
• Prioritize and complete the assigned training on time. Perform other duties as assigned.

Requirements :

Behaviors :

Supervisory Responsibilities

Work Environment / Physical Demands

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process :

All legitimate RQM+ job opportunities are listed on our official careers page : rqmplus.com / careers

Every candidate going through the interview process will participate in a voice and / or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

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